Roche Diagnostics Operations, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0297-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.

Product Classification:

Class II

Date Initiated: September 22, 2015

Date Posted: November 25, 2015

Recall Number: Z-0297-2016

Event ID: 72427

Reason for Recall:

Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.

Status: Terminated

Product Quantity: 1

Code Information:

During transport from the Bulk Loader Module (BLM), catalog number 07135645001, to the cobas p 512/p 612 pre-analytical instruments, sample tubes may inadvertently open and spill, causing contamination of the system.

Distribution Pattern:

Distributed to TX only.

Voluntary or Mandated:

Voluntary: Firm initiated